This invention relates to apparatus and methods for diagnostic assessment of psychological conditions that enable a patient or user to collect important diagnostic measures of psychological conditions or behavior for transmittal to and analysis by a health care professional. The invention further relates generally to communication systems for remote monitoring of individuals, and in particular to a networked system for remotely monitoring individuals and for communicating information to the individuals through the use of script programs.
The traditional method of diagnosing and assessing psychological conditions involves periodic clinical sessions in which a clinician attempts to obtain insights of a patient""s condition by conducting interviews and, in some cases, conducting tests. This traditional method of psychological testing and evaluation is often very lengthy and, as a result, costly. Moreover, many psychological conditions and behavior patterns are not easily diagnosed during a series of routine clinical visits because the condition or behavior is situation-dependent and, thus, may not be observable in a clinical setting. Further, the manifestations or behavior patterns of certain disorders are heterogeneous in nature, which complicates identification and diagnosis. Specifically, where a high degree of heterogeneity is present, standardized and normalized diagnostic measures intended to identify a particular or preferred regimen of therapy often do not exist. Under such conditions, the identification and diagnosis of a psychological condition or behavior pattern becomes very subjective, often resulting in an even larger number of diagnostic clinical sessions and higher costs. Lower rates of diagnostic accuracy and efficacy also result.
Many people suffering from psychological disorders are unable to obtain clinical assistance because of the high cost of diagnosis and treatment. Further, even where cost is not of a major deterrent, many people lose confidence in the clinical procedure and cease attending clinical sessions when diagnostic assessment becomes difficult and lengthy. Difficulties can be encountered even by patients that persevere. Between their periodic clinical visits, they usually are left on their own with no encouragement or treatment.
Advances in the various fields of electronics and telecommunications have had a significant impact on medical diagnostic and monitoring equipment, including the development of devices that can be used in the home or other non-clinical settings. Recent advancement with respect to self-care health monitoring of afflictions such as diabetes were set forth in my patent application Ser. No. 07/977,323, filed Nov. 17, 1992, entitled xe2x80x9cMODULAR MICROPROCESSOR-BASED HEALTH MONITORING SYSTEMxe2x80x9d now issued as U.S. Pat. No. 5,307,263.
Some experiments and trials have been conducted with respect to incorporating computers and similar electronic equipment in arrangements for psychological testing and assessment that is performed in a clinical setting. Very recently, some experiments and trials have been conducted in which a patient uses a microprocessor device such as a xe2x80x9cpalm-top computerxe2x80x9d to record behavioral information between clinical sessions and, in some cases, for limited therapeutic purposes. However, adoption of modem microprocessor and communication technology to diagnosing, monitoring or treating psychological disorders has not progressed at the same rate as technological advances in areas of medicine that relate to physiological conditions.
There are numerous reasons why microprocessors and modem communication techniques have not been widely applied to devices for psychological diagnoses, evaluation or treatment. As previously mentioned, the behavior attendant many psychological disorders is situation dependent. Thus, to be useful, a device must be relatively small, relatively easy to use and unobtrusive so that a patient or subject can use the device in an appropriate environment and is comfortable with using the device in that environment. Cost and efficacy are also important factors if use of the device is to result in a reduction in the professional time and other costs associated with diagnosis and treatment of various psychological conditions.
In order to provide a diagnostic tool that can be used in settings other than clinical sessions, other criteria should be met. For example, provision should be made for a clinician or other health care professional to easily acquire data gathered by the diagnostic tool and to analyze that data. Further, to achieve optimum utilization, the diagnostic tool should be extremely versatile, lending itself to adaptation to the assessment of various psychological conditions. Preferably, the device should be adaptable enough to allow a clinician to establish diagnostic routines suited for various species of the same general psychological disorder of even for a particular individual. Versatility sufficient for use of the device in at least limited monitoring and therapeutic procedures is also desirable.
For all of the above reasons, a need exists for improved methods and apparatus for psychological evaluation and assessment. This is especially true with disorders such as depression, anxiety, schizophrenia, addiction, eating disorders, attention deficit disorders, attention deficit and hyperactivity disorder, and other psychological and behavioral problems which are highly stimulus-dependent (i.e., may be manifested primarily or only in situations that are difficult to synthesize in a clinical environment). The extreme heterogeneity of these psychological conditions has complicated diagnosis and treatment, a drawback that leaves many adults and children with chronic conditions that are handicaps both from the social and economic standpoint.
Providing reliable and accurate tests for diagnosing psychological disorders in children has been a substantial problem. In particular, prevalent childhood psychological disorders such as Attention Deficit Hyperactivity Disorder and Attention Deficit Disorder are difficult to assess because attention is a multi-construct neuropsychological process that includes sustained attention (vigilance) and selective attention (i.e., the ability to maintain attention in the presence of distractions and the ability to appropriately shift attention). Children with Attention Deficit Disorder and Attention Deficit and Hyperactivity Disorder are often impulsive, requiring a relatively high degree of motivation in order to complete tasks that employ cognitive skills appropriate to their particular age group. Moreover, current assessment tests for Attention Deficit Disorder and Attention Deficit Hyperactivity Disorder are relatively subjective, and even when effectively administered, basically provide only an evaluation of whether a child exhibits a deficit in his or her ability to focus and maintain attention. That is, current tests have been successful only in identifying a large heterogeneous group that exhibit the basic symptoms of Attention Deficit Hyperactivity Disorder. Little success has been obtained relative to assessing the degree of neuropsychologic mechanism impairment. Thus, current diagnostic techniques do not identify homogeneous subgroups of children having Attention Deficit Hyperactivity Disorder, which is needed in order to prescribe and administer effective therapy.
Developing diagnostic and therapeutic tools for psychological assessment and treatment of children is especially challenging. To obtain essential, unbiased information for diagnosis of Attention Deficit Hyperactivity Disorder or Attention Deficit Disorder, a child being tested must be at ease and must be motivated since children with these disorders are easily distracted when faced with situations requiring continued attention and/or routine, relatively tedious tasks. Thus, if cognitive tests are employed, they must be appealing to younger children, but not leave older children bored and unmotivated to perform well. Otherwise, test results will be skewed and diagnosis made even more difficult.
In the United States alone, over 100 million people have chronic health conditions, accounting for an estimated $700 billion in annual medical costs. In an effort to control these medical costs, many healthcare providers have initiated outpatient or home healthcare programs for their patients. The potential benefits of these programs are particularly great for chronically ill patients who must treat their diseases on a daily basis. However, the success of these programs is dependent upon the ability of the healthcare providers to monitor the patients remotely to avert medical problems before they become complicated and costly. Unfortunately, no convenient and cost effective monitoring system exists for the patients who have the greatest need for monitoring, the poor and the elderly.
Prior attempts to monitor patients remotely have included the use of personal computers and modems to establish communication between patients and healthcare providers. However, computers are too expensive to give away and the patients who already own computers are only a small fraction of the total population. Further, the patients who own computers are typically young, well educated, and have good healthcare coverage. Thus, these patients do not have the greatest unmet medical needs. The patients who have the greatest unmet medical needs are the poor and elderly who do not own computers or who are unfamiliar with their use.
Similar attempts to establish communication between patients and healthcare providers have included the use of the Internet and Internet terminals. Although Internet terminals are somewhat less costly than personal computers, they are still too expensive to give away to patients. Moreover, monthly on-line access charges are prohibitive for poor patients.
Other attempts to monitor patients remotely have included the use of medical monitoring devices with built-in modems. Examples of such monitoring devices include blood glucose meters, respiratory flow meters, and heart rate monitors. Unfortunately, these monitoring devices are only designed to collect physiological data from the patients. They do not allow flexible and dynamic querying of the patients for other information, such as quality of life measures or psycho-social variables of illness.
Prior attempts to monitor patients remotely have also included the use of interactive telephone or video response systems. Such interactive systems are disclosed in U.S. Pat. Nos. 5,390,238 issued to Kirk et al. on Feb. 14, 1995; 5,434,611 issued to Tamura on Jul. 18, 1995; and 5,441,047 issued to David et al. on Aug. 15, 1995. One disadvantage of these systems is that they either require a patient to call in to a central facility to be monitored or require the central facility to call the patient according to a rigid monitoring schedule.
If the patients are required to call the central facility, only the compliant patients will actually call regularly to be monitored. Non-compliant patients will typically wait until an emergency situation develops before contacting their healthcare provider, thus defeating the purpose of the monitoring system. If the central facility calls each patient according to a monitoring schedule, it is intrusive to the patient""s life and resistance to the monitoring grows over time.
Another disadvantage of these conventional interactive response systems is that they are prohibitively expensive for poor patients. Further, it is difficult to identify each patient uniquely using these systems. Moreover, these systems are generally incapable of collecting medical data from monitoring devices, such as blood glucose meters, respiratory flow meters, or heart rate monitors.
In view of the above, it is an object of the present invention to provide a simple and inexpensive system for remotely monitoring patients and for communicating information to the patients. It is another object of the invention to provide a system which allows flexible and dynamic querying of the patients. It is a further object of the invention to provide a system which combines querying of patients with medical device monitoring in the same monitoring session. Another object of the invention is to provide a monitoring system which incurs lower communications charges than those incurred by conventional monitoring systems. A further object of the invention is to provide a monitoring system which may be used at any time convenient for a patient.
These and other objects and advantages will become more apparent after consideration of the ensuing description and the accompanying drawings.
This invention addresses the previously discussed need for new and useful apparatus and methods for diagnostic assessment of psychological conditions, providing a valuable adjunct and supplementation to traditional clinical assessment. Apparatus arranged in accordance with the invention is extremely versatile, being suitable for use in diagnostic assessment of various psychological conditions and being especially well suited for assessment of conditions that affect children such as Attention Deficit Disorder and Attention Deficit Hyperactivity Disorder. The invention also is extremely versatile in that it is suited for use in a clinical setting as well as use in remote locations such as the home, school, or workplace.
Basically, apparatus configured in accordance with the invention includes a programmable microprocessor unit that is responsive to program instructions that are supplied by an external source. In the disclosed embodiment, a receptacle is included in the programmable microprocessor-based unit for receiving an external (xe2x80x9cremovable/insertablexe2x80x9d) memory unit which includes a digital storage medium for storing program instructions that control operation of the programmable microprocessor-based unit. In other embodiments, the program instruction instructions can be transferred to memory circuits of the microprocessor-based unit by various digital data transmission systems and techniques.
The programmable microprocessor-based unit also includes circuitry for generating a video display in accordance with program instructions stored in an internal memory of the microprocessor-based unit and/or the digital storage medium of the external memory unit. In the operation of the invention, the displayed video signals interactively prompt a patient or user to operate one or more switches that are located on the microprocessor-based unit. Preferably, the programmable microprocessor-based unit also includes a sound generator operable for producing selected tones, single words or simple phrases of simulated speech, simple musical passages, and other sounds appropriate to the video display during the operation of the microprocessor-based unit.
In the currently preferred embodiments of the invention, the microprocessor-based unit is a compact video game system, with the program instructions being provided by an external memory unit that corresponds to a game cartridge. The invention can employ either a hand held video game such as the compact video game system manufactured by Nintendo of America Inc. under the trademark xe2x80x9cGAME BOY,xe2x80x9d or less compact video game systems such as the xe2x80x9cSUPER NESxe2x80x9d video game, which also is marketed by Nintendo of America Inc. As is well known, hand held video games of the type mentioned are unitary devices that include a display screen and control switches for operating the video game. On the other hand, the larger video game systems operate in conjunction with a television set or video monitor and consist of a console unit, which receives a game cartridge, and one or more controllers, which include at least a portion of the switches for operating the video game system. Use of either type of video game system has several general advantages, including the widespread availability and low cost of such systems. Further, such systems provide an easy-to-use, unobtrusive device that can be used either in a clinical setting or other environment such as the home, school, or workplace. Moreover, the video display can be structured to provide motivation for a patient or user and, in at least some instances, the same or an additional program cartridge can provide appropriate educational or therapeutic video displays and processes.
Use of the video game system for the programmable microprocessor-based unit of the invention is especially advantageous with children because of the popularity and widespread acceptance of all types of video games. In accordance with the invention, video and audio sequences are preferably presented in game-like format with animation that is suitable for children or other selected age groups.
Regardless of whether a video game system is employed, the programmable microprocessor-based unit can be used to analyze the data obtained during a diagnostic assessment procedure. In some cases, a full analysis will be performed so that the information that is transmitted or returned to a clinician is in a final form. In other situations, partial (or even no) analysis of gathered diagnostic information is performed by the programmable microprocessor-based unit. In those situations, partial (or full) analysis is performed at the clinician""s facility or, alternatively, at a facility that gathers information for analysis and subsequent relay to the clinician.
Systems that are arranged in accordance with the invention include two components in addition to the above-discussed programmable microprocessor-based unit: (1) a programmable digital signal processor; and, (2) a communication link for allowing signal transmission between the programmable microprocessor-based unit and the programmable digital signal processor. In some arrangements of the invention, the programmable digital signal processor is a personal computer that is located at the clinic or other facility of the health care professional. In these arrangements, the programmable microprocessor-based unit can be located at the clinician""s facility with the communication link for coupling signals between the programmable microprocessor-based unit and the clinician""s computer being an electrical cable that provides a RS232 communication link or some other digital signal transmission arrangement. However, a primary advantage of the invention is use of the microprocessor-based unit at a location that is remote from the clinician""s facility (e.g., use between clinical sessions in an environment appropriate to assessment of the psychological condition of interest). At least two basic types of communication links allow assessment of the psychological condition to be made at a subject""s home or other location that is remote from the clinician""s facility.
First, an RS232 serial data port or other means for coupling digital signals to the central processing unit of the clinician""s personal computer can be connected to a cable that is adapted for receiving an external memory unit (e.g., memory cartridge) that is used with the programmable microprocessor-based unit to gather assessment data. In such an arrangement, the external memory unit is interconnected with the clinician""s computer to access stored signals that represent information gathered during a diagnostic assessment procedure that was performed earlier at a subject""s home or other suitable location. In many situations, the clinician""s computer will have been previously interconnected with the external memory unit to allow the clinician to establish stored program instructions that will implement a desired diagnostic assessment procedure when the patient or user operates the microprocessor-based unit in conjunction with the memory unit.
The second type of communication link that allows the diagnostic assessment procedure to be conducted at a location other than the clinician""s facility involves the use of various types of signal transmission media. For example, the digital data signal processor (e.g., personal computer) employed by the clinician can include an external or internal modem for receiving and transmitting digital signals via the various types of conventional telephone systems. Likewise, a modem and associated conventional data management circuitry can be either included in or interconnected with the microprocessor-based unit to allow information gathered during a diagnostic assessment procedure to be transmitted to the clinician for review and analysis. In some cases, it may also be advantageous to use the data transmission link for remote programming of the user""s external memory unit, thereby permitting changes to be made in the diagnostic procedure of a particular patient or user without a visit to the clinician""s office.
Transmission media other than a telephone system can be used for coupling signals between a clinician""s digital data processing system and a remotely located programmable microprocessor-based unit that is used for diagnostic assessment of psychological conditions. For example, recently developed interactive audio/visual systems using coaxial cable or optical fiber can be employed as well as other types of digital networks that provide information services and communication between users. In some of these arrangements, the digital data signal processor need not be located at the clinician""s facility. That is, the invention can be implemented so that the digital signal processor is a clearinghouse that in effect functions as a central server that is capable of functioning with a relatively large number of programmable microprocessor units and, in addition, capable of serving the needs of at least several clinicians. In these arrangements, the clearinghouse digital signal processor collects and stores diagnostic assessment information transmitted to the clearinghouse from any number of programmable microprocessor-based units. Information is then provided to the appropriate clinician or clinical facility by facsimile or data transmission techniques. Alternatively, the information can be printed and delivered to the appropriate clinician.
The disclosed embodiments of the invention are configured and programmed for diagnostic assessment of Attention Deficit Disorder and Attention Deficit Hyperactivity Disorder. The currently preferred realizations of the disclosed embodiment allow a clinician to selectively configure sequences of tests (xe2x80x9ctasksxe2x80x9d) that fall into the two basic categories: delay reaction tasks and performance-paced continuous performance tasks. During a delay reaction task, the programmable microprocessor-based unit operates to first generate an audible and/or visual warning signal to alert the user that the microprocessor-based unit will soon produce an audio, visual, or audiovisual target stimulus. When the target stimulus is produced, the user or patient responds by activating a switch or control of the microprocessor-used unit. Preferably, the time between the warning stimulus and the target stimulus within a predetermined range that is selected by the clinician, with each particular time delay being randomly selected through programmed operation of the microprocessor-based unit. For each delayed reaction task, a signal is generated indicating whether the user reacted to the target stimulus and, if so, the time that elapsed between generation of the target stimulus and the user""s operation of the selected switch. Collecting and storing the user""s reaction times for a sequence of delayed reaction tasks allows subsequent analysis by the system digital data processor to obtain information such as a record of reaction time versus time delay, the user""s best (fastest) reaction time, the user""s mean reaction time, and/or the standard deviation of reaction times. In some situations, it may also be advantageous to store the delayed reaction task information so that analysis can be performed that allows the detection of trends such as whether the user""s reaction time generally increased or decreased as the sequence of delayed reaction tasks progressed. Such information may indicate an increase or decrease in attention level with time.
In the currently preferred realizations of the disclosed embodiment of the invention, the visual delayed reaction task includes the display of a car, the model of which selected by the user prior to initiation of the diagnostic procedure. The car is shown at a starting line with a traffic signal having a red, yellow, and green light being prominently displayed in the foreground. Initially, the red light is illuminated, a warning signal is then provided to the user by illuminating the yellow light and, when the microprocessor-selected time delay has elapsed, the green light is illuminated to provide the target stimuli. In the currently preferred realizations of the disclosed embodiments of the invention, the words xe2x80x9cready . . . set . . . goxe2x80x9d are synthesized by the sound generator of the microprocessor-based unit.
During the continuous performance tasks, the system user observes the system display while target stimuli pass across it. The object is for the user to activate a switch or control of the microprocessor-based unit when target stimuli are at a predetermined location on the display. For example, in the currently preferred realizations of the disclosed embodiments of the invention, the previously mentioned car is displayed so that it appears to be passing by trees that are located along the side of a road. The target stimulus is a specified type of fruit (e.g., an orange, apple, lemon, or cluster of grapes) on the tree. The object is for the user to activate the switch or control of the microprocessor-based unit when a predetermined stimulus appears (e.g., an apple). When the switch or control is activated a hand and arm move upwardly from the car and, if the switch is timely activated, the fruit is captured. When the user correctly identifies and captures a target stimulus, the time interval between appearance of target stimuli is decreased by a predetermined amount. On the other hand, if the user does not properly respond to a target stimulus, the time interval between target stimuli is increased.
During the conduction of a sequence of continuous performance tasks, information is recorded to reflect the number of target stimuli correctly identified, the number of target stimuli missed, the number of responses to non-target stimuli, the number of correct, but delayed, responses, and the final interstimulus time interval.
Audio continuous performance tasks are also provided wherein the user is to respond to certain audio signals while ignoring others. For example, in the currently preferred realizations of the disclosed embodiments, the car shown on the system display unit is passing along a dark road with a small portion of the road passing under the car""s headlights. A low frequency xe2x80x9cradar beepxe2x80x9d is sounded for each non-target stimulus, and a high frequency radar beep is sounded to represent the target stimulus. Although the display is relatively dark, the bases of the trees can be seen and when the user properly responds to a target stimulus, a hand swings upwardly from the car to catch the fruit.
The battery of tests provided by the currently preferred embodiments of the invention also include continuous performance tasks with various distractions. For example, in the above-discussed realization in which the user activates a switch or control of the microprocessor-based unit to catch a predetermined type of fruit as a car passes across the system display, moving objects such as hopping frogs, fluttering butterflies, and flying saucers are periodically and randomly displayed. In the audio continuous performance tasks, the distractions consist of synthesized speech such as xe2x80x9cNow!xe2x80x9d or xe2x80x9cGo!.xe2x80x9d During sequences of continuous performance tasks that include distractions, the number of distractions that cause user reaction are recorded as well as the information recorded during continuous performance task sequences that do not include distractions.
The invention presents a networked system for remotely monitoring an individual and for communicating information to the individual. The system includes a server and a remote interface for entering in the server a set of queries to be answered by the individual. The server is preferably a world wide web server and the remote interface is preferably a personal computer or network terminal connected to the web server via the Internet. The system also includes a remotely programmable apparatus for interacting with the individual. The apparatus is connected to the server via a communication network, preferably the Internet. The apparatus interacts with the individual in accordance with a script program received from the server.
The server includes a script generator for generating the script program from the queries entered through the remote interface. The script program is executable by the apparatus to communicate the queries to the individual, to receive responses to the queries, and to transmit the responses from the apparatus to the server. The server also includes a database connected to the script generator for storing the script program and the responses to the queries.
The apparatus has a communication device, such as a modem, for receiving the script program from the server and for transmitting the responses to the server. The apparatus also has a user interface for communicating the queries to the individual and for receiving the responses to the queries. In the preferred embodiment, the user interface includes a display for displaying the queries and user input buttons for entering the responses to the queries. In an alternative embodiment, the user interface includes a speech synthesizer for audibly communicating the queries and a speech recognizer for receiving spoken responses to the queries.
The apparatus also includes a memory for storing the script program and the responses to the queries. The apparatus further includes a microprocessor connected to the communication device, the user interface, and the memory. The microprocessor executes the script program to communicate the queries to the individual, to receive the responses to the queries, and to transmit the responses to the server through the communication network.
In the preferred embodiment, the system also includes at least one monitoring device for producing measurements of a physiological condition of the individual and for transmitting the measurements to the apparatus. The apparatus further includes a device interface connected to the microprocessor for receiving the measurements from the monitoring device. The measurements are stored in the memory and transmitted to the server with the responses to the queries. The server also preferably includes a report generator connected to the database for generating a report of the measurements and responses. The report is displayed on the remote interface.